FDA Adverse Event
Malfunction
Summary report: N
LAG SCREWDRIVER 380X110MM
MDR report key: 1259172
·
Received November 12, 2008
Report
- Report Number
- 9610622-2008-00236
- Event Type
- Malfunction
- Date Received
- November 12, 2008
- Date of Event
- October 17, 2008
- Report Date
- October 17, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HXX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT#S K33511, K558205. DEVICE NOT RETURNED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT ALL LAG SCREWDRIVERS WERE DAMAGED DURING EXTRACTIONS OF THE NAIL. ALL EXTRACTIONS WERE DONE AS DESCRIBED IN OPERATION TECHNIQUE. NO EXCESSIVE FORCE WAS USED. IT WAS ALSO STATED THAT ANCHORING LAG SCREW DRIVER INTO THE LAG SCREW WAS DIFFICULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAG SCREWDRIVER 380X110MM | INSTRUMENT | HXX | STRYKER OSTEOSYNTHESIS KIEL | NA | K464831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |